Use of unlicensed and off-label drugs in neonates in a Brazilian university hospital.

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dc.creatorAdriana Cristina de Souza Gonçalves
dc.creatorAdriano Max Moreira Reis
dc.creatorAna Carolina Gusmão Marçal
dc.creatorMaria Cândida Ferrarez Bouzada
dc.date.accessioned2024-09-04T15:31:26Z
dc.date.accessioned2025-09-09T01:05:52Z
dc.date.available2024-09-04T15:31:26Z
dc.date.issued2017
dc.format.mimetypepdf
dc.identifier.doi10.1590/s2175-97902017000300252
dc.identifier.issn21759790
dc.identifier.urihttps://hdl.handle.net/1843/75939
dc.languageeng
dc.publisherUniversidade Federal de Minas Gerais
dc.relation.ispartofBrazilian Journal of Pharmaceutical Sciences
dc.rightsAcesso Aberto
dc.subjectMedicamentos - Utilização
dc.subjectUso Off-Label
dc.subjectTerapia medicamentosa - Gerenciamento
dc.subjectNeonatologia
dc.subjectHospitais universitários - Brasil
dc.subject.otherDrugs-use-University Hospital-Brazil
dc.subject.otherDrug-useoff-label-unlicensed
dc.subject.otherDrug therapy
dc.subject.otherNeonatology
dc.subject.otherUniversity Hospital-Brazil.
dc.titleUse of unlicensed and off-label drugs in neonates in a Brazilian university hospital.
dc.typeArtigo de periódico
local.citation.epage10
local.citation.issue3
local.citation.spage1
local.citation.volume53
local.description.resumoThis study was designed to investigate the use of off-label and unlicensed drugs in a Neonatal Care Unit (NCU) and to compare the frequency of use of off-label drugs according to the drug regulatory agencies in Brazil (Agência Nacional de Vigilância Sanitária-ANVISA) and the United States Food and Drug Administration (FDA). A prospective observational study was carried out in the NCU. Prescriptions were classified as off-label and unlicensed using both ANVISA and FDA criteria. A total of 157 newborns and 1187 prescriptions were analyzed. The most prescribed drug was fentanyl (9.3%), followed by multivitamin (8.4%) and gentamicin (7.9%). According to ANVISA criteria, there were 665 (56.0%) off-label prescriptions and 86 (7.2%) unlicensed prescriptions and 95.5% of newborns received at least one drug off-label. By contrast, according to FDA criteria, there were 592 (49.9%) off-label prescriptions and 84 (7.1%) unlicensed prescriptions, and 72.0% of newborns received at least one drug off-label. The off-label use of drugs registered by ANVISA differed significantly from that of drugs registered by the FDA. There was a high frequency of off-label and unlicensed drug use in the investigated NCU, and there was an inverse relationship between off-label and unlicensed usage and the gestational age of the newborns.
local.publisher.countryBrasil
local.publisher.departmentFAR - DEPARTAMENTO DE PRODUTOS FARMACÊUTICOS
local.publisher.initialsUFMG
local.url.externahttps://www.scielo.br/j/bjps/a/xdLBTgjykmnm47jHFFrDQMf/?lang=en#

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